ID

31646

Descrizione

A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00992745

collegamento

https://clinicaltrials.gov/show/NCT00992745

Keywords

16/09/18 16/09/18 -
16/09/18 16/09/18 -

Titolare del copyright

See clinicaltrials.gov

Caricato su

16 settembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00992745

model
Dettagli

Eligibility Prostate Cancer NCT00992745

1 moduli

StudyEvent: Eligibility
1. Eligibility Prostate Cancer NCT00992745

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Criteria

Item Group

Gender | Age

Item

1. male aged 18 years or older

boolean

C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])

Informed Consent | Protocol Compliance

Item

2. signed written informed consent and willingness to comply with protocol requirements

boolean

C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])

Prostate carcinoma | Prostate Medical History | Biopsy of prostate | Metastatic Lesion Biopsy

Item

3. histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a metastatic lesion.

boolean

C0600139 (UMLS CUI [1])
C0033572 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0194804 (UMLS CUI [3])
C1513183 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])

Neoplasm Metastasis Bone scan abnormal | Neoplasm Metastasis CT scan abnormal | Neoplasm Metastasis MRI scan abnormal

Item

4. evidence of metastatic disease as documented by an abnormal bone scan and ct scan or mri plus:

boolean

C0027627 (UMLS CUI [1,1])
C0740353 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0436539 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0436540 (UMLS CUI [3,2])

Castration naive | Castration Sensitive | Antiandrogen therapy naive | Antiandrogen therapy Sensitive

Item

castration/anti androgen therapy naïve/sensitive:

boolean

C0007344 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0007344 (UMLS CUI [2,1])
C0332324 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3,1])
C0919936 (UMLS CUI [3,2])
C0279492 (UMLS CUI [4,1])
C0332324 (UMLS CUI [4,2])

Item

1. gleason score ≥ 7 and psa ≥ 2.0 ng/ml with history of prostatectomy or primary radiation therapy of the prostate gland and prior undetectable psa or; psa > 10.0 ng/ml if intact prostate, or

boolean

C3203027 (UMLS CUI [1])
C0201544 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0033572 (UMLS CUI [3,2])
C0205266 (UMLS CUI [3,3])
C0033573 (UMLS CUI [4])
C1522449 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C0458690 (UMLS CUI [5,3])
C0138741 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
C3827727 (UMLS CUI [6,3])

Gleason score | Prostate specific antigen measurement

Item

2. gleason score ≤ 6 and psa is ≥ 20 ng/ml, or

boolean

C3203027 (UMLS CUI [1])
C0201544 (UMLS CUI [2])

Gleason score | Prostate-Specific Antigen Doubling Time | Prostate specific antigen measurement

Item

3. gleason score ≥ 8 and any doubling of psa, or psa > 0.5 ng/ml, or

boolean

C3203027 (UMLS CUI [1])
C0138741 (UMLS CUI [2,1])
C2986483 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])

TNM clinical staging | Gleason score

Item

4. clinical stage 3 and gleason score ≥ 8

boolean

C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])

Antiandrogen therapy Initiation Previous

Item

if on anti androgen therapy, must have initiated therapy at least 4 weeks prior to treatment.

boolean

C0279492 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])

Castration Resistant | Antiandrogen therapy Resistant

Item

castration/anti androgen therapy resistant:

boolean

C0007344 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0279492 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])

Item

1. patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (lhrh analogue); anti androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on anti androgens who have demonstrated a > 3 month duration of beneficial response to anti androgens; progression is demonstrated by any of the following:

boolean

C0242656 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0029189 (UMLS CUI [3])
C1513054 (UMLS CUI [4])
C1518041 (UMLS CUI [5])
C0002842 (UMLS CUI [6,1])
C2349954 (UMLS CUI [6,2])
C0016384 (UMLS CUI [7])
C0068771 (UMLS CUI [8])
C0285590 (UMLS CUI [9])
C0002842 (UMLS CUI [10,1])
C1704632 (UMLS CUI [10,2])

Prostate-Specific Antigen Progression | Raised prostate specific antigen Quantity | Prostate specific antigen measurement

Item

i. psa progression: 2 serial rising psa determinations at least 14 days apart over the psa nadir, with the last measurement ≥ 2 ng/ml

boolean

C0138741 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])

Measurable Disease Progression | Disease Progression

Item

ii. progression of measurable disease, or progression of non measurable disease as defined by:

boolean

C1513041 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])

Disorder of soft tissue | Lesion New Quantity | Disease Worsening | Bone Diseases | Bone scan abnormal Quantity

Item

i. soft tissue disease: the appearance of one or more new lesions, and/or unequivocal worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response, or ii. bone disease: appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre castration studies if there was no response.

boolean

C0263978 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0005940 (UMLS CUI [4])
C0740353 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])

Lesion Pre-existing Increased Bone scan | Independent of Progression

Item

iii. increased uptake of pre existing lesions on bone scan does not constitute progression.

boolean

C0221198 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
C0203668 (UMLS CUI [1,4])
C0332291 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])

Testosterone measurement | Medical Castration | Male Castration

Item

iv. testosterone ≤ 50 ng/dl achieved via medical or surgical castration.

boolean

C0523912 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C0007347 (UMLS CUI [3])

Gender | Fertility Contraceptive methods | Sexual Abstinence | Contraception, Barrier | Relationship Partner Oral contraception

Item

5. male subjects who are fertile agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method throughout the study period. a second form of barrier birth control must be utilized if a subject's partner is using oral contraception until at least seven days after the last injection.

boolean

C0079399 (UMLS CUI [1])
C0015895 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0036899 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0439849 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0029151 (UMLS CUI [5,3])

Karnofsky Performance Status

Item

6. karnofsky performance is ≥ 50

boolean

C0206065 (UMLS CUI [1])

Hematologic function | Renal function | Liver function

Item

7. adequate hematologic, renal and liver function:

boolean

C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])

White Blood Cell Count procedure | Absolute neutrophil count

Item

wbc ≥ 2.0×103/mm3 (anc > 1.0 x 103 mm3)

boolean

C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])

Platelet Count measurement

Item

platelet count ≥ 75×103/mm3

boolean

C0032181 (UMLS CUI [1])

Hemoglobin measurement

Item

hemoglobin ≥ 9.0 g/dl

boolean

C0518015 (UMLS CUI [1])

Creatinine measurement, serum

Item

creatinine ≤ 2.5 mg/dl

boolean

C0201976 (UMLS CUI [1])

Serum total bilirubin measurement

Item

total bilirubin ≤ 2x uln

boolean

C1278039 (UMLS CUI [1])

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Item

ast, alt ≤ 5x uln

boolean

C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Karnofsky Performance Status

Item

1. karnofsky performance status of < 50

boolean

C0206065 (UMLS CUI [1])

Prostate implant brachytherapy Permanent | Palladium-103 Implants | Iodine-125 Implants

Item

2. subject has received a permanent prostate brachytherapy implant within the last 3 months for 103pd implants or 12 months for 125i implants

boolean

C0860343 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C0303566 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C0796396 (UMLS CUI [3,1])
C0021102 (UMLS CUI [3,2])

Diagnostic radioisotope

Item

3. subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment

boolean

C0360048 (UMLS CUI [1])

Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status

Item

4. subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study

boolean

C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C2348568 (UMLS CUI [3])

Radiopharmaceuticals | Strontium-89 | Samarium 153

Item

5. any treatment with radiopharmaceuticals, e.g. strontium 89 and samarium 153 within 6 months prior to enrollment

boolean

C0182638 (UMLS CUI [1])
C0281385 (UMLS CUI [2])
C0677942 (UMLS CUI [3])

Item

6. ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. patients who demonstrate an antiandrogen withdrawal response, defined as a > 25% drop in psa within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non steroidal anti androgen, are not eligible until the psa rises above the nadir observed after anti androgen withdrawal

boolean

C0022625 (UMLS CUI [1])
C0002842 (UMLS CUI [2])
C0016384 (UMLS CUI [3])
C0068771 (UMLS CUI [4])
C0285590 (UMLS CUI [5])
C0002842 (UMLS CUI [6,1])
C2349954 (UMLS CUI [6,2])
C1704632 (UMLS CUI [6,3])
C0178414 (UMLS CUI [7])
C1320169 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])

Diphosphonates Dosage unchanged

Item

7. initiation of bisphosphonate therapy within 28 days prior to enrollment. patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study

boolean

C0012544 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])

Medical condition compromises Research data | Medical condition compromises Study Protocol | Medical condition compromises Completion of clinical trial | Medical condition compromises Follow-up | Circumstances compromise Research data | Circumstances compromise Study Protocol | Circumstances compromise Completion of clinical trial | Circumstances compromise Follow-up

Item

8. subject has any medical condition or other circumstances which, in the opinion of the investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow up examinations

boolean

C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
C1821459 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0681873 (UMLS CUI [5,3])
C1821459 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C2348563 (UMLS CUI [6,3])
C1821459 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C1821459 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C3274571 (UMLS CUI [8,3])

Study Subject Participation Status Inappropriate

Item

9. subject is determined by the investigator to be clinically unsuitable for the study

boolean

C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])

Item

10. if the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response

boolean

C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C0011900 (UMLS CUI [4,3])
C1514873 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C1515974 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C1707251 (UMLS CUI [6,2])
C2911690 (UMLS CUI [6,3])
C1514873 (UMLS CUI [7,1])
C1707251 (UMLS CUI [7,2])
C0677874 (UMLS CUI [7,3])

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Keywords

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Titolare del copyright

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Commenti dell'articolo per :

Eligibility Prostate Cancer NCT00992745

Eligibility Prostate Cancer NCT00992745

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